Kornimate/medical-research-clean huggingface dataset:
nitroglycerin ointment for preventing bone loss in postmenopausal women

Conditions: Osteoporosis; Osteopenia

Summary: osteopenia and osteoporosis cause thinning of bone tissue and loss of bone density over time. the purpose of this study is to determine the safety and effectiveness of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women. study hypothesis: on average, participants in the base therapy cohort who receive placebo ointment control and calcium/vitamin d will lose more bone density than participants in the nitroglycerin cohort over the 36-month period.

imbalance in the activities of osteoclasts (cells responsible for bone loss) and osteoblasts (cells responsible for bone formation) may lead to fractures, osteopenia, and osteoporosis in postmenopausal women. during postmenopause, decreased estrogen levels and decreased nitric oxide production occur; estrogen replacement therapy has been shown to restore serum nitric oxide levels to normal. reversing nitric oxide deficiency by using nitroglycerin may prevent further bone loss. the nitroglycerin as an option: value in early bone loss (novel) study will test the safety and efficacy of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women. patients will be enrolled in the study for 3 years and will be randomly assigned to one of two groups. the first group will receive nitroglycerin ointment, while the second group will receive placebo ointment. all patients will be given a calcium supplement with vitamin d to be taken daily, and will be instructed to rub the given ointment on their skin daily. study visits will occur at month 2 and every six months after month 2. phone interviews will be conducted with patients every 2 months throughout the study.

Eligibility criteria:
inclusion criteria: * postmenopausal for a minimum of 13 months * lumbar spine t-score of 0 to -2.5 (0 to -2.0 if over 60 years old) by dual energy x-ray absorptiometry (dexa) (i.e., evidence of normal bone mass or osteopenia) * body mass index (bmi) between 18 and 32 * planning to live in the greater new brunswick, nj, area for at least 3 years exclusion criteria: * radiographically or dexa-morphometrically proven vertebral or hip fracture * conditions requiring routine use of sublingual, transdermal, or oral nitrates * significant postmenopausal symptoms that require estrogen therapy * metabolic bone diseases other than postmenopausal bone loss (e.g., active hyperthyroidism, hyperparathyroidism, paget's disease of bone, etc.) * insulin-dependent diabetes mellitus * significant migraine headaches * history of renal calculi * cancer within 5 years prior to study entry * any condition causing an anticipated life expectancy of less than 3 years * failure to maintain 75% to 125% compliance with open-label calcium with vitamin d regimen during the screening period

Keywords: human female osteoporosis postmenopausal nitric oxide nitroglycerin calcium vitamin d
1000 eyes lens biometry study: artificial intelligence for intraocular lens power calculation

Conditions: Cataract

Summary: the main purpose of the study is to develop an ai approach to improve intraocular lens power calculations.

cataract surgery is one of the most commonly performed surgeries worldwide and has a high postoperative patient satisfaction rate. despite significant improvement in measurement methods and artificial lens power calculation formulas, miscalculations and subsequently refractive error still occur after cataract surgery. most current artificial lens calculation methods use regression formulas. the concept of artificial intelligence (ai) has only recently found use and only in a rudimentary way. examples include the hill-rbf calculator and the ladas superformula, but at least the "superformula" does not use a true ai approach and the results are no better than those obtained with conventional methods. the main purpose of the study is to develop an ai approach to improve intraocular lens power calculations. the data will be used for the following analysis: * to compare the new ai method with conventional and modern formula (main question) * to compare the refractive error for different eye lengths * to use a ray tracing method to quantify sources of error in patients with a refractive surprise of at least 1.0 diopter * to evaluate a novel concept of outlier testing using a modified nonparametric walsh test this study will be multi-center and partially prospective. data from 1000 patients who have already had cataract surgery will be analyzed. all patients will be invited for a visit to the recruitment clinic and the measurements will be performed.

Eligibility criteria:
inclusion criteria: * pseudophakic (at least one eye): cataract surgery between 4 weeks and 24 months prior to recruitment * if both eyes would be suitable for the study only the right eye will be included, if only one eye is suitable for the study, this eye will be included * pre-operative swept-source oct biometry available (no ultrasound measurement for axial eye length) * uncomplicated cataract surgery * age 21 years and older exclusion criteria: * multifocal iols * combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery) * best corrected distance visual acuity below 0.5 snellen * in case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Keywords: lens power calculation biometry artificial inteligence
efficacy study of blinatumomab clean up early residual disease for newly diagnosed pediatric b lymphoblastic leukemia

Conditions: B-Cell Lymphoblastic Leukemia

Summary: the goal of this clinical trial is to evaluate the efficacy of blinatumomab in pediatric patient with newly diagnosed acute b-lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 mrd ≥ 0.1% (low-risk) or day 19 mrd ≥ 0.01% (intermediate-risk). the main question is: • if the flow cytometric mrd negative (\<0.01%) rate and the ngs- mrd negative (\<0.0001%) rate at the end of induction for patients received blinatumomab will be superior to historical control (d46mrd in the cccg-all2020 protocol). participants will: * take 14 days full dose blinatumomab; * with bone marrow evaluated before and after blinatumomab treatment.


Eligibility criteria:
inclusion criteria: * age older than 1 month to younger than 18 years. * diagnosis of acute lymphoblastic leukemia by bone marrow morphology. * immunophenotyping: acute b-lymphoblastic leukemia; * meet one of the following situations: a. provisional low-risk: d19mrd ≥ 0.1%; b. provisional intermediate-risk: d19mrd ≥ 0.01%; * subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the ethics committee exclusion criteria: * sigm+; * all evolved from chronic myeloid leukemia (cml); * down's syndrome, or major congenital or hereditary disease with organ dysfunction; * other secondary leukemias; * cns involvement; * history of epilepsy; or convulsions within the last month; * known underlying congenital immunodeficiency or metabolic disease; * congenital heart disease with cardiac insufficiency; * treated with glucocorticoids for ≥14 days, or abl kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression); * initial diagnosis of high risk; * d46mrd ≥1%.

Keywords: children b-cell lymphoblastic leukemia blinatumomab
restart or stop antithrombotic randomised trial in france

Conditions: Cerebral Hemorrhage

Summary: restart- fr is a randomised controlled trial for adults surviving spontaneous intracerebral haemorrhage who had taken an antithrombotic drug (i.e. anticoagulant or antiplatelet medication) for the prevention of vaso-occlusive disease before the ich. restart- fr is testing whether a policy of starting antiplatelet drugs (one or more of aspirin, clopidogrel, or dipyridamole, chosen at investigator's discretion) results in a beneficial net reduction of all serious vascular events over two years compared with a policy of avoiding antiplatelet drugs.

more than one third of the adults with a stroke due to bleeding into the brain - known as brain haemorrhage - are taking drugs to prevent clotting when they have a brain haemorrhage. these patients had previously suffered illnesses like angina, heart attack, or stroke due to blood vessel blockage, which is why they are treated with drugs to prevent further clots occurring. these drugs are usually stopped when the brain haemorrhage occurs. but when patients recover from brain haemorrhage, they and their doctors are often uncertain about whether to restart these drugs to prevent further clots occurring, or whether to avoid them in case they increase the risk of brain haemorrhage happening again. in this preliminary study of 292 such people who survive a brain haemorrhage, we will study the potentially beneficial effects of three antiplatelet drugs (one or more of aspirin, clopidogrel, or dipyridamole, chosen by the patient's physician) on the risks of heart attack, stroke and other clotting problems as well as their effect on the risk of a brain haemorrhage happening again.

Eligibility criteria:
inclusion criteria: * patient age ≥18 years. * spontaneous intracerebral hemorrhage confirmed by imaging * patient had been taken antithrombotic drug(s) for the prevention of vaso-occlusive disease for at least 1 week before ich onset * randomisation more than 24 hours after ich onset. * patient and their doctor are uncertain about whether to start or avoid antiplatelet drugs. * brain imaging that first diagnosed the ich is available. participant or representative consent. exclusion criteria: * intracerebral hemorrhage associated with : a vascular malformation (avm, arterial aneurysm, cavernoma); a secondary hemorrhagic infarction; a cerebral venous thrombosis; a tumor * patients with a formal indication of restarting oral anticoagulants despite the ich (eg mechanical heart valves or pulmonary embolism under 6 months)

Keywords: stroke intracranial hemorrhage intracerebral hemorrhage antithrombotic drugs brain microbleeds
clinical trial of yh14618 in patients with degenerative disc disease

Conditions: Disc Degenerative Disease

Summary: research hypothesis: there will be a greater proportion of vas responders defined as those who achieve ≥ 50% reduction from baseline in vas for low back pain at week 12 following intradiscal injection of yh14618 compared to placebo. patients have been diagnosed as one or two symptomatic lumbar degenerative disc disease defined as pfirrmann grade 2 to 4 using mri. patients have suffered from persistent low back pain with at least 3 months of conservative therapy and must have low back pain measured by vas≥4 cm and modified oswestry disability index (modi) ≥30% at the baseline.


Eligibility criteria:
inclusion criteria: * patients diagnosed as one or two symptomatic early lumbar (l1/l2 \~ l5/s1) degenerative disc disease defined as pfirrmann grade 2 to 4 using mri performed within 4 weeks prior to randomization. * patients have suffered from persistent low back pain with at least 3-month conservative therapy. * patients have low back pain measured by vas≥4cm and modi≥30% at screening and randomization visit (day 0). exclusion criteria: * clinically significant spine compression fracture, spinal stenosis, or spinal instability. * clinically significant sacroiliac joint dysfunction, facet joint pain, or those who are suspected. * modic change type iii assessed by x-ray and mri * history of spine surgery * neurologic disorders. * any other systemic disease which can influence spine such as rheumatoid arthritis, ankylosing spondylitis, or autoimmune disease. * participation in other clinical trials with intradiscal injection (eg, phase 1/2a yh14618-201 trial, or cell therapy, etc.)
control of metabolic and cardiovascular risk in patients with schizophrenia and overweight

Conditions: Schizophrenia

Summary: to analyse the progress of modifiable metabolic risk factors (blood pressure, cigarette smoking, waist perimeter, bmi, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months. to analyse the perceived health status and the level of functioning and disability of patients with schizophrenia and overweight and their progress at 3, 6 and 12 months. to assess the progress of the symptoms of the disease at 6 and 12 months.

consecutive patient sampling. any investigational site four consecutive patients with diagnosis of schizophrenia (dsm-iv tr) and overweight (bmi more or equal to 25 kg/m2)

Eligibility criteria:
inclusion criteria: * patients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (dsm-iv tr) * patients with bmi (body mass index) more or equal to 25 kg/m2 * patients or their legal representative have provided written informed consent exclusion criteria: * patients are unable to complete or to understand health questionnaires in spanish language * patients are currently enrolled on clinical trials or other investigational studies

Keywords: schizophrenia, overweight, cardiovascular risk, obesity
assessment of efficacy and safety in patients with non-cancer-related pain and opioid-induced constipation

Conditions: Opioid-Induced Constipation (OIC)

Summary: the purpose of this study is to evaluate the effect and safety of nktr-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (lir).


Eligibility criteria:
inclusion criteria: * provision of written informed consent prior to any study-specific procedures. * men and women who are between the ages of ≥18 and \<85 years. * self-reported active symptoms of oic at screening (\<3 sbms/week and experiencing ≥1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of bms over the previous 4 weeks); and documented confirmed oic (\<3 sbms/week on average over the 2-week oic confirmation period. * receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies for a minimum of 4 weeks prior to screening for non-cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression. * willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 2-week oic confirmation period and the 12-week treatment period, and to use only bisacodyl as rescue medication if a bm has not occurred within at least 72 hours of the last recorded bm. exclusion criteria: * patients receiving opioid regimen for treatment of pain related to cancer. * history of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer. * medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation. * other issues to the gastrointestinal tract that could impose a risk to the patient. * pregnancy or lactation.

Keywords: non-cancer-related pain, opioid-induced constipation
women urinary incontinence prevalence study (wuips)

Conditions: Female Urinary Incontinence

Summary: the goal of this multicenter prospective and prevalence observational study is to punctually investigate and describe prevalence, predictors, quality of life and costs of urinary incontinence (ui) among female patients, female caregivers and female personnel in four hospitals in northern italy: san raffaele hospital in milan, san raffaele turro hospital in milan, zingonia policlinico san marco (bg) and policlinico san pietro in ponte san pietro (bg).

expected results the collection of data and information through this study will aim to: 1. understand the percentage of middle-aged women with ui. 2. describe the socio-demographic and clinical characteristics of women with ui. 3. identify ui predictors. 4. describe the quality of life, social impact and costs of women with ui.

Eligibility criteria:
inclusion criteria * female sex * middle age (40-65 years old) * informed consent signed * comprehension of written and spoken italian language * female outpatients intended for any hospital unit (outpatient clinic, day surgery and day hospital patients included) and every female caregiver respecting the previous inclusion criteria, recruited at the central admission and at the private admission of the four hospitals involved * female workers (healthcare professionals and administrative personnel) of the four hospitals exclusion criteria * male sex * young age (\ 65 years) * pregnant women * puerperium women (up to 40 days post-partum) * women who had undergone urinary and gynecology surgery
obese pregnant women: optimizing fetal ultrasound

Conditions: Obesity; Fetal Malformation

Summary: this study aim to evaluate the quality of fetal ultrasound in obese pregnant women. the hypotheses is that an early ultrasound will improve the quality of the ultrasound in obese.

ultrasound examination for fetal anomaly is especially challenging in obese gravida. the foetus is more likely to have congenital anomalies and imaging in these patients is technically more difficult. the investigators hypotheses that an earlier ultrasound with alternative technics will improve the quality and thereby improve the identification of anomalies. by using transvaginal ultrasound and abdominal ultrasound at the window just above the symphysis, were the subcutaneous fat is known to be thinner, the investigators hope to achieve a better overview. this will be done by evaluating fetal ultrasound at three different gestational ages (ga); ga 13, 15 and 21 weeks.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * bmi ≥ 30 kg/m2 * bmi: 18,5-25 kg/m2 * understand and speak danish and thereby be able to give confirmed consent. exclusion criteria: * multiple gestations * overweight (bmi: 25-29,9 kg/m2) * alcohol or drug abuse * chronically diseases before pregnancy as diabetes, hypertension, or thyroid diseases * gastric bypass or other obesity related surgery

Keywords: ultrasound mid-trimester obesity pregnancy
right ventricle function after major right lung resection

Conditions: Right Ventricular Dysfunction; Pneumonectomy; Status

Summary: major lung resection is associated with high post-operative morbidity and mortality and significant long-term decreased functional capacity, especially due to cardiorespiratory complications. rv (right ventricle) ejection, pulmonary artery pressure and tone are tightly coupled. the rv is exquisitely sensitive to changes in afterload. when pulmonary vascular reserve is compromised rv ejection may be also compromised, increasing right atrial pressure and limiting maximal cardiac output. acute increase in rv outflow resistance, as may occur with acute pulmonary embolism will cause acute rv dilatation and, by ventricular interdependence, markedly decreased lv (left ventricle) compliance, rapidly spiraling to acute cardiogenic shock and death. most of the studies on rv function after lung resection are small and have found different results, and sometimes conflicting findings. as far as the investigators know, there are no data on the incidence of the rv dysfunction after major lung resection (pneumonectomy/bilobectomy) and it's not clear if there is some direct association between the rv dysfunction and post-operative complications. if so, early detection of rv dysfunction after major lung resection could provide the opportunity for interventional therapy with consequent possible improvement of these patients' prognosis.

the aim of this study is to identify the incidence of early rv systolic dysfunction (defined as tricuspid annular plane systolic excursion (tapse) \< 17 cm, s' (tdi) \< 10 cm/s) and estimate the rv-pa (right ventricle-pulmonary artery) coupling as indicated by guazzi et all. (tapse/paps ratio, where paps is the systolic pulmonary artery pressure) after major lung resection (bilobectomy and pneumonectomy) using echocardiography, and to assess if these modifications (rv dysfunction and rv-pa coupling) may be associated with post-operative cardiopulmonary complications occurring during the hospitalization period. investigators also intend to evaluate if these changes are associated with impaired functional capacity at 3 months after surgery.

Eligibility criteria:
inclusion criteria: * adults patients undergoing right pneumonectomy * adults patients undergoing pulmonary bilobectomy exclusion criteria: * left pneumonectomy (it will not permit tte postoperatively) * completion pneumonectomy * patients suffering from any myocardial disease * preceding pulmonary embolism * pregnancy * potential pregnancy * patients enrolled into another trial

Keywords: right ventricle disfunction pneumonectomy echocardiography
autologous platelets rich plasma (aprp) treatment vs saline dressing for the management of diabetic foot ulcer

Conditions: Diabetic Foot Ulcer

Summary: the aim of this study is to compare between the platelet rich plasma and normal saline dressing in the healing diabetic foot ulcers. it will be a randomized controlled trial.


Eligibility criteria:
inclusion criteria: * diabetic foot wound less than 5cm in greatest diameter non healing duration greater than 3 months non infected palpable distal pulses exclusion criteria: * infected wound wound greater than 5 cm patient having hba1c greater than 8% renal failure wound with bone exposed or having osteomyelitis
the effect of creative drama on the development of anxiety, empathy and communication skills in nursing education

Conditions: Psychiatric Nursing

Summary: this work; the aim of this study is to determine the effect of the education program, which was created with the creative drama method based on travelbee's "human-to-human relationship" theory, on the teaching and practice of mental health and psychiatric nursing course, on reducing the anxiety of students and improving their empathy and communication skills.

in psychiatric nursing education; it is known that classical education methods are not sufficient to reduce students' anxiety and stigma, and to strengthen communication and empathy. for this reason, there is a need for training methods that will increase in-depth learning and communication skills and empathy in the field. in this research, the creative drama education method was arranged in accordance with the requirements of mental health and psychiatric nursing education and a training program was developed. within the scope of the research, this training program was applied to the students who completed the theoretical education of psychiatric nursing. in order to measure the effectiveness of the research training program, it was planned in a quantitative design as a randomized controlled intervention study and in a mixed method in qualitative design in order to examine students' views on the method.

Eligibility criteria:
inclusion criteria: * being residing in the city center of ankara volunteering to participate in the research, being a 4th year nursing student and having completed the mental health and diseases nursing course, lack of clinical experience in communicating with individuals with mental illness (health vocational high school graduate), not having received training in communicating with individuals with mental illness before (students repeating a grade). not having been diagnosed with any mental illness no mental illness in first degree relatives exclusion criteria: * living outside the city center of ankara to fill in the research data collection forms incompletely, not completing the creative drama education based on human-human relationship theory, refusal to participate in the research not meeting the criteria for inclusion in the research

Keywords: psychiatric nursing ,creative drama, empathy, anxiety